Maryann Janowski

973-***-**** aczheh@r.postjobfree.com

Professional Profile

Quality Assurance (QA) » Quality Control (QC) » Inspections » Process Improvement

QA, QC and total quality management (TQM) trained professional with 15+ years of experience; expertise spans inspection and documentation for healthcare/biomedical technology and industrial manufacturing. Balances multiple competing projects and priorities, and builds influence without authority to drive collaboration and cooperation on cross-functional quality and production teams. Extremely detail-oriented and thorough; possesses a strong working knowledge of quality standards and compliance regulations, including ISO 13485: 2003, ISO 9001: 2008 and FDA 21 CFR Part 820.

Reporting & Documentation Verification Testing Reporting & Analysis Calibration Documentation Final Product Testing

Data Entry & Database Administration Quality Audits Product Quality Specifications Certificates of Analysis

Global Quality Standards & cGMP Compliance Non-Conformance Testing Corrective Action/Preventive Action (CAPA)

Gage Calibrations

Professional Experience

Crane Aerospace and Electronics, Parsippany, NJ (02/2016 – 11/11/2016) QC Inspector / Contract

Daily final quality control inspection of multi-layer PCB hybrid modules in accordance with customer print, IPC-A-610 criteria, and internal prints also performing a documentation audit to ensure compliance of customer end item data package. Prepare final QC status report in Microsoft Excel; update hourly performance report of product throughput; and complete performance checklist to generate Pareto chart.

In-Process inspection of multi-layer PCB hybrid modules in accordance with customer specifications and IPC-A-610 as needed.

Support Quality Assurance Engineering process improvement initiatives as related to final QC inspection.

Communicate final hardware status and issues with QA Engineering, Management, and Site Leadership as needed.

Zimmer TMT, Parsippany, NJ (05/2014 – 8/31/2015) QC Technician / Contract

A leading provider of orthopedic products.

Executed gage R & R studies on product specific lines measuring critical key features of implants.

Verified measurements of product performing mechanical inspections using comparators, calipers, micrometers, height indicators and pin gages.

Analyzed and approved calibration certificates for accuracy and compliance.

Assisted in the calibration lab performing equipment calibrations, entering results and updating the calibration database.

Operated Instron machine testing product material for strength.

TX Technology Corporation, Denville, NJ (10/2013 – 12/2013) – QC Technician / Contract

Designers and manufacturers of intelligent products for telecommunications and industrial applications.

Executed software and application testing/QC protocols on automatic monitoring and control systems for cable pressurization environmental and building alarms.

Verified functionality of integrated systems following software upgrade, and drafted updated documentation to reflect the new procedures.

Tronex International, Mount Olive, NJ (06/2013 – 07/2013) – Product Development Assistant / Contract

Leading provider of disposable personal protective equipment (PPE) with cross-contamination control and infection-protection solutions for healthcare, foodservice, hospitality, government and industrial/manufacturing.

Completed special projects in preparation for new product launch, and utilized attention to detail and organizational skills to add value to the entire product team during planning phases.

Organized internal and competitive sample inventory to streamline retrieval and analysis.

Analyzed products in the repackaging area and dispositioned merchandise according to quality specifications.

St. Jude Medical, Hackettstown, NJ (08/2012 – 11/2012) – Quality Assurance Administrator / Contract

Global medical device manufacturer with 16,000 employees and four main areas of focus, cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.

Processed quality assurance documentation and certification requests for product shipments, and maintained compliance and accuracy for finished goods and production orders.

Scanned and electronically filed documentation and performed reconciliations on production work orders.

Reviewed Device History Records (DHR) for accuracy and compliance with GMP and internal requirements.

Roche Molecular Systems, Branchburg, NJ (11/2008 – 07/2012) – Calibration Data Coordinator

Business area of Roche Diagnostics that develops, manufactures and supplies innovative medical diagnostic products, services, tests, platforms to researchers, physicians, patients, hospitals, laboratories and blood banks around the world.

Managed office administration for the Calibration Manager, Principal Calibration Specialist, and a team of Calibration Engineers and coordinated, scheduled, and documented calibrations for extremely sensitive lab and manufacturing equipment.

Analyzed calibration data and discrepancies to identify non-conformances and developed/executed CAPA processes.

Archived data and maintenance records, and produced materials and documentation for internal and external auditors.

Supervised and scheduled calibration vendors, and maintained departmental instrument and equipment files.

Inspected clean-lab equipment in full protective gear, and maintained detailed logs of equipment changes, transfers, and updates.

Siemens Healthcare Diagnostics, Flanders, NJ (05/2001 – 10/2008) – Quality Assurance Associate

Medical diagnostics leader with monitoring and management solutions for laboratories of all sizes that include immunoassay, chemistry, hematology, molecular, urinalysis, and blood gas testing systems and automation, informatics and other services.

Conducted incoming and final product inspection and testing of Immulite Invitro medical instruments, and provided critical reports and analysis to senior management in support of portfolio optimization and improvement projects.

Produced weekly audit reports with graphical illustrations of instrument output, deviations from specs, and final results of pass/fail testing.

Performed a cost-benefit analysis on the facility’s archive systems; recommended consolidation with potential $40K savings over a five-year period.

Authored QC and manufacturing documentation for the group, including Standard Operating Procedures (SOPs), Work Instructions, Inspection Log Sheets, and Repair Request Forms.

Training & Professional Development

Extensive Company Sponsored Training including:

Total Quality Management (TQM) Achieving Success Without Authority Focusing on Results

Listening Skills, Basic through Advanced Professionalism & Customer Service

Technical Skills

Microsoft Office – Word, Excel, Access, PowerPoint, Outlook

Database Oracle, SAP, Blue Mountain RAM, GageTrak, Instron Bluehill

Professional Memberships

American Society for Quality (Former Member)

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